OMNI Knee KC-36020Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841690101529), received between Oct 30, 2017 and Sep 28, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Appropriate Device Problem Term/Code Not Available

  A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2026. The original surgery is dated (b)(6) 2026. The reason for revision is reported ruptured quad tendon. Surgeon previously performed a total knee on the Patient and decided to swap the poly and bolt as a precaution. During the revision the tibial insert and retaining bolt were removed and replaced with a new implants.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50913157 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2016. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 18603182 ↗
• InjurySep 20, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS PATIENT FALL. DURING THE REVISION THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 15455017 ↗
• InjuryDec 14, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2007. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 13005322 ↗
• InjuryNov 3, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12746085 ↗
• InjurySep 28, 2021Naturally Worn

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2009. THE REASON FOR REVISION POLY WEAR. DURING THE REVISION A POLY SWAP OCCURRED REPLACING THE TIBIAL INSERT AND RETAINING BOLT.

  Patient problems: Insufficient Information

  MAUDE report 12542457 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A BILATERAL KNEE REVISION SURGERY ON (B)(6) 2021. THIS WAS THE FIRST SURGERY OF A 2-STEP REVISION. THE ORIGINAL SURGERY DATE IS (B)(6) 2014. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12507531 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A BILATERAL KNEE REVISION SURGERY ON (B)(6) 2021. THIS WAS THE FIRST SURGERY OF A 2-STEP REVISION. THE ORIGINAL SURGERY DATE IS (B)(6) 2014. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12507524 ↗
• InjurySep 21, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A BILATERAL KNEE REVISION SURGERY ON (B)(6) 2021. THIS WAS THE SECOND SURGERY OF A 2-STEP REVISION. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12507374 ↗
• InjuryMay 26, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 11882745 ↗
• InjuryMay 25, 2021Loose or Intermittent Connection

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2011. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 11874370 ↗
• InjuryMay 3, 2021Unstable

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11762908 ↗
• InjuryDec 15, 2020Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL COMPONENTS WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS

  Patient problems: Unspecified Infection

  MAUDE report 11009420 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REPLACED THE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 10723356 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 9281618 ↗
• InjuryMar 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION THE TIBIAL INSERT SIZE 2X16MM AND BOLT WERE REMOVED AND REPLACED WITH A LARGER SIZE.

  Patient problems: No Information

  MAUDE report 8387958 ↗
• InjuryJan 31, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 X 10MM INSERT AND RETAINING BOLT WAS REVISED TO A NEW SIZE 2 X 14MM INSERT AND RETAINING BOLT.

  Patient problems: No Code Available

  MAUDE report 7231726 ↗
• InjuryDec 27, 2017Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, AND RETAINING BOLT. IN ADDITION, TWO MODULAR STEMS WERE IMPLANTED ALONG WITH A TIBIAL AUGMENT AND AUGMENT BOLT AND NEW PATELLAR COMPONENT.

  Patient problems: Unspecified Infection

  MAUDE report 7148245 ↗
• InjuryOct 30, 2017Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF KNEE HYPEREXTENDING. DURING THIS REVISION, THE TIBIAL INSERT WAS REVISED FROM A SIZE 2 X 10MM INSERT TO SIZE 2 X 20MM

  Patient problems: Failure of Implant

  MAUDE report 6988190 ↗